Ghaiath Hussein Assistant Professor, Dept of Medical Ethics, Faculty of Medicine

1. Review of Non-National (International) Research Conducted in Less Developed Countries: Challenges and OpportunitiesSeptember 16, 2011 Beirut, Lebanon Ghaiath Hussein Assistant Professor, Dept of Medical Ethics, Faculty of Medicine King Fahad Medical City, Riyadh (KSA) Email: ghaiathme@gmail.com, Phone: 00966-566511653

2. Outline of presentation • Research in context... (the KMC) • Why are developing countries targeted by int’l research? • Do we need to worry about “foreign research”? • Challenges facing ethical review of int’l research • Few suggestions to go ahead • Take home messages

3. Research in context...the KMC Research Publications Conferences Statistics Knowledge Management Cycle Clinicians Cochraine EMBase Policy makers

4. Better Ethics for Better Health? Here Comes RECs!

5. Is it always that perfect?

6. Where are we now?

7. Why are poorer countries targeted? • The comparatively low cost, less troublesome trials • The high burden and variety of diseases • Weak national review & judiciary systems (laws & courts) • Lack of national research agendas & fund • Facilitated e-communications (easier remote monitoring) • Abundant, less-educated, more compliant subjects “We can recruit a third more patients, in a third less time and we can save at least a third of the cost”, Vijay Kumar, Neeman Medical International • Political and economic corruption

8. Why would it be ethically troublesome? • Poverty & ignorance make participants exploitable • Host countries takes more burden/harm than benefit • The irrelevance of the study objectives or methods to the studied population • Cultural & communication barriers (consent?) • Commercial and academic agendas --> COI • Lack of adequate governmental protection to participants • Research benefits are NOT adequately shared with researched communities

9. Challenges to review of int’l research in LMICs

10. Opportunities (Who should do what?)

11. Opportunities (Who should do what?)

12. Empower your country by int’l research • Accept ONLY int’l research that: • Addresses research questions of national benefit • Has a local partner (university, research center) • Builds research capacity of the national partner (e.g. provide equipment) • Has training component • Has national/local co-investigators • Provides service (or other benefits) to studied communities • Abides to signed contracts & agreements (e.g. for local result sharing, IP rights, patenting, sharing research benefits) Remember: You have the legal power to let a research go or stop!

13. Take Home Messages • Research is only the means to better health through better knowledge – not an end in itself. • Research ethics guides research to develop science with the least harm (& max. benefit) to its participants • Int’l research is NOT a threat unless our research systems are too weak to benefit from it • To empower our review capacity we need: self-development, communication, collaboration and partnerships.

14. Questions & Discussions Thank You